Associate Director, Statistical Programming

Alkermes

  • Waltham, MA
  • Permanent
  • Full-time
  • 1 month ago
Job Category: Research and DevelopmentDegree Level: Master's DegreeJob Description:The Associate Director of Statistical Programming, as a member of the Biostatistics & Statistical Programming Department, will contribute to Alkermes to achieve the goals of continuing growth in neuroscience. The Associate Director will combine technical and project management skills to lead programmers to develop and validate SAS programs to produce high quality deliverables for in-house and outsourced projects in CDISC compliance to meet regulatory requirements. In addition, this individual will support the automation and innovation within programming group to drive effective and efficient statistical programming.This is a hybrid, on-site position based in Waltham, MA.Primary Responsibilities
  • Function as lead programmer to coordinate all activities related to study or project level statistical programming activities.
  • Design and develop programming specifications and SAS programs for producing and validating CDISC compliant datasets to support the generation of outputs for regulatory submission.
  • Produce and validate regulatory submission tables, figures and listings, support ad-hoc exploratory analysis in a timely fashion and of high quality
  • Design, develop, implement and maintain innovative statistical programming automation reporting tools to effectively support multiple projects.
  • Provide project management and technical guidance to ensure operational and technical excellence. Mentor junior level staff in programming practices, implementation of standards and project management.
  • Represent statistical programming in cross-functional teams. Work in close collaboration with other functions including biostatistics, clinical operations, data management and regulatory operations to define deliverables, develop timelines and ensure alignment of expectations
  • Work with IT to develop and maintain programming environment to ensure data security and efficient analysis and reporting
Basic Requirements
  • Advanced degree strongly preferred (M.S. or Ph. D) with strong analytical skills
  • Minimum 8+ years experiences in pharmaceutical/biotech and/or CRO setting
Preferred Requirements
  • Proven expert in SAS programming and analytical skills using BASE SAS, SAS/STAT, SAS/GRAPH and SAS MACROS etc.
  • Extensive CDISC SDTM and ADaM knowledge with significant experience writing ADaM specifications using robust and detailed instructions. Strong hands-on SAS programing skills for clinical trial reporting. Experience with electronic FDA submission.
  • Prefer proficiency in other data analysis programming languages, such as R and Python. Ability to learn new programming language quickly and be motivated to utilize them in the clinical development field.
  • Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
  • Strong interpersonal, organizational, and multi-tasking skills
  • Excellent attention to detail and problem-solving skills
  • Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
  • Good written and oral presentation skills and ability to communicate effectively
  • Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment
  • Neuroscience experience is a plus
  • SAS LSAF experience is a plus
About Us:Why join Team Alkermes?Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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